Spinal prostheses

ABSTRACT

An article including a spinal prosthesis having a unitary body with at least three attachment points attachable to spinal structure, the unitary body including a flexure assembly positioned between first and second attachment members, wherein flexure of the flexure assembly permits movement of the first attachment member relative to the second attachment member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 USC §119 to U.S. ProvisionalPatent Application, Ser. No. 60/517,888, filed Nov. 7, 2003, and is acontinuation of U.S. patent application Ser. No. 10/750,860 filed Jan.5, 2004, which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention is generally related to apparatus and methods forspinal prostheses.

BACKGROUND OF THE INVENTION

Spinal stenosis, as well as spondylosis, spondylolisthesis,osteoarthritis and other degenerative phenomena may cause back pain,especially lower back pain. Such phenomena may be caused by a narrowingof the spinal canal by a variety of causes that result in the pinchingof the spinal cord and/or nerves in the spine. Fusion of two or moreadjacent vertebrae has been to alleviate back pain. However, fusion ofvertebrae can be disfavored because fusion tends to cause degenerativephenomena in the fused vertebrae to migrate to adjacent vertebralcomponents that have not been fused.

SUMMARY OF THE INVENTION

The present invention seeks to provide a novel spinal prosthesis, as isdescribed more in detail hereinbelow. The prostheses disclosed hereinare particularly advantageous for the posterior portion of the spine,but the invention is not limited to the posterior portion of the spine.

There is thus provided in accordance with an embodiment of the presentinvention an article including a spinal prosthesis having a unitary bodywith at least three attachment points attachable to spinal structure,the unitary body including a flexure assembly positioned between firstand second attachment members, wherein flexure of the flexure assemblypermits movement of the first attachment member relative to the secondattachment member.

The spinal prosthesis can include one or more of the following features.For example, the first and second attachment members may be formed withmounting holes adapted for a mechanical fastener to pass through andinto the spinal structure. The first and second attachment members mayinclude sidewalls separated by a gap, the gap being adapted forreceiving therein a posterior portion of the spine. The flexure assemblymay be attached to the first and second attachment members by means of atenon-and-mortise joint. The first and second attachment members mayinclude at least one pair of opposing resilient pawls adapted forgripping the portion of the spine. The flexure assembly may include morethan one flexure member between the first and second attachment members.At least a portion of the flexure assembly may be attached to the firstand second attachment members with a plurality of locking members.Alternatively, at least a portion of the flexure assembly may beintegrally formed with the first and second attachment members. Thelocking members may include plate-like elements secured to the first andsecond attachment members with mechanical fasteners. The locking membersmay include at least one lug extending generally perpendicularly fromthe plate-like elements, around which at least one stopper is engaged.The flexure assembly may include a boot placed at least partially aroundinner portions of the first and second attachment members, the bootbeing connected to the first and second attachment members. The boot maybe elastomeric. The flexure assembly may be adapted to flexomnidirectionally. A plurality of pedicle screws may be attached to orintegrally formed with the spinal prosthesis. The pedicle screws mayinclude polyaxial pedicle screws having a threaded shank and a polyaxialswivel head. The threaded shank and/or the polyaxial swivel head may beattached to or integrally formed with the spinal prosthesis. The firstand second attachment members may include mounting arms rotatablymounted in a housing, one portion of each mounting arm being disposed ina hollow chamber formed in the housing, and another portion of eachmounting arm protruding from the housing through an aperture formed inthe housing. The flexure assembly may include a multi-part articulatingassembly, including a first joint member that has a convex contour thatarticulates with a second joint member that has a concave contour thatcorresponds to and glides over the convex contour of the first jointmember, the first and second joint members being attached to orintegrally part of the attachment members. A stopper may be providedthat limits the flexure of the flexure assembly and limits relativemovement of the attachment members with respect to one another.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIGS. 1A and 1B are simplified pictorial illustrations of a structure ofa human spine, in particular the lumbar vertebrae, FIGS. 1A and 1Brespectively showing side and top views of the L4 and L5 vertebrae;

FIG. 1C is a simplified perspective illustration of an elastomericspinal prosthesis, constructed and operative in accordance with anembodiment of the present invention;

FIG. 2 is a simplified perspective illustration of an elastomeric spinalprosthesis, constructed and operative in accordance with anotherembodiment of the present invention;

FIG. 3 is a simplified perspective illustration of an elastomeric spinalprosthesis, constructed and operative in accordance with yet anotherembodiment of the present invention, adapted for attachment to aposterior portion of the spine and to other vertebral structure, e.g., afacet or pedicle of the same vertebra;

FIG. 4 is a perspective view of a superior attachment member of theprosthesis shown in FIG. 3;

FIG. 5 is a perspective view of an inferior attachment member of theprosthesis shown in FIG. 3;

FIG. 6 is a perspective view of an elastomeric member of the prosthesisshown in FIG. 3;

FIGS. 7A and 7B are simplified pictorial illustrations, from twodifferent perspective views, of an elastomeric spinal prosthesis,constructed and operative in accordance with still another embodiment ofthe present invention;

FIGS. 8A and 8B are simplified sectional illustrations, respectivelyalong front and side facing planes, of the elastomeric spinal prosthesisshown in FIGS. 7A and 7B; and

FIGS. 8C and 8D are simplified sectional illustrations of an alternativeconstruction of a flexure assembly of the elastomeric spinal prosthesisof FIGS. 8A and 8B.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1A and 1B, which illustrate a structureof a human spine, in particular the lumbar vertebrae.

FIGS. 1A and 1B illustrate the fourth and fifth lumbar vertebrae L4 andL5, respectively, in a lateral view (while in anatomic association) andin a superior view (separately). The lumbar vertebrae (of which thereare a total of five) are in the lower back, also called the “small ofthe back.”

As is typical with vertebrae, the vertebrae L4 and L5 are separated byan intervertebral disk 125. The configuration of the vertebrae L4 and L5differ somewhat, but each vertebra includes a vertebral body 110, whichis the anterior, massive part of bone that gives strength to thevertebral column and supports body weight. A vertebral arch 112 isposterior to the vertebral body 110 and is formed by right and leftpedicles 114 and lamina 116. The pedicles 114 are short, stout processesthat join the vertebral arch 112 to the vertebral body 110. The pedicles114 project posteriorly to meet two broad flat plates of bone, calledthe lamina 116.

Seven other processes arise from the vertebral arch 112. A spinousprocess 118 and two transverse processes 120 project from the vertebralarch 112 and afford attachments for muscles, thus forming levers thathelp the muscles move the vertebrae. Two superior articular processes122 project superiorly from the vertebral arch 112 and two inferiorarticular processes 124 project inferiorly from the vertebral arch 112.The superior articular processes 122 of a vertebra are located oppositecorresponding inferior articular processes 124 of an adjacent vertebra.Similarly, inferior articular processes 124 are located oppositecorresponding superior articular processes 122 of an adjacent vertebra.The intersection of a vertebra's superior articular processes 122 withthe inferior articular processes 124 of an adjacent vertebra form ajoint, called a zygapophysial joint, or in short hand, a facet joint orfacet 126. Facet joints 126 found between adjacent superior articularprocesses 122 and inferior articular processes 124 along the spinalcolumn permit gliding movement between the vertebrae L4 and L5.

Reference is now made to FIG. 1C, which illustrates a spinal prosthesis10, constructed and operative in accordance with an embodiment of thepresent invention.

Prosthesis 10 may include an upper (superior) vertebral attachmentmember 20 attachable to one of the spinous processes 118 (not shown inFIG. 1C), and a lower (inferior) vertebral attachment member 21attachable to an adjacent spinous process 118. Attachment members 20 and21 may be rigid or non-rigid, formed of materials including, but notlimited to, a biocompatible material such as a metal, e.g., stainlesssteel, titanium or titanium alloy, cobalt chromium alloys, plastics orother hard, rigid materials or any combination of the above.

An elastomeric member 22 (also referred to as a flexure assembly) isplaced between and may be integrally formed with or attached to upperand lower vertebral attachment members 20 and 21. Elastomeric member 22may be made from a compliant material including, but not limited to,polyurethane containing materials, silicone containing materials,polyethylene based elastomers, hydrogels, and polypropylene containingmaterials. Elastomeric member 22 may flex in any direction, which mayhelp reduce tension between the attachment members 20 and 21 duringmovement of the spine. The flexure of elastomeric member 22 permits theattachment members 20 and 21 to move relative to one another. This mayhelp install the prosthesis in the body by overcoming misalignmentsbetween the parts of the prosthesis and the mounting holes in the body.

In order to install prosthesis 10, any material or body structure suchas ligaments may be removed or moved to the side temporarily in order toexpose adjacent spinous processes. For example, a laminactomy (cuttinginto the lamina 116 and removing at least a portion thereof) may beperformed through a posterior incision. Afterwards, the attachmentmembers 20 and 21 may be attached to the exposed spinous processes 118of the adjacent vertebrae.

In the embodiment of FIG. 1C, but not necessarily, upper and lowervertebral attachment members 20 and 21 are formed with mounting holes 24adapted for a mechanical fastener (not shown) to pass through and intothe spinous processes 118. For example, any fastener or fasteners, suchas but not limited to, screws, bolts, rivets, nails, tacks and nuts maypass through holes 24 to firmly attach attachment members 20 and 21 tothe spinous process 118.

The vertebral attachment members 20 and 21 may have sidewalls 25separated by a gap 23 (forming a U-shape). The spinous process 118 orany posterior portion of the spine, for example, may be received snugly(or loosely) in gap 23 prior to fastening with the mechanical fastener.A hole, or holes, may be drilled into or right through the spinousprocess 118 at a place opposite holes 24 in order to use the mechanicalfasteners to firmly attach the attachment members 20 and 21 to thespinous processes 118.

In the embodiment of FIG. 1C, but not necessarily, elastomeric member 22may be attached to or integrally formed with upper and lower vertebralattachment members 20 and 21 by means of a tenon-and-mortise joint. Thetenon-and-mortise joint may comprise tenons 27 (protrusions) that matewith mortises (grooves) 29. However, the invention is not limited tothis type of joint or connection, and other types of joints,connections, fastenings, adhesive bonding and the like may also be used.

Reference is now made to FIG. 2, which illustrates a spinal prosthesis30 having upper and lower vertebral attachment members 32 and 34 thatcan be attached to a spinous process 118 without having to drill into orthrough the spinous process. Thus, a smaller incision to install theprosthesis 30 may be used than to install the prosthesis 10.

This embodiment may include upper and lower vertebral attachment members32 and 34 that have one or more pairs of opposing resilient pawls 36mounted on a base 38 and adapted for gripping the spinous process 118.The pawls 36 apply a spring force to tightly grip the spinous process118. The attachment members may thus be pushed into place and tightly“snap on” the spinous process 118. (The spinous process 118 is receivedin gap 23 as before.) In the above-described embodiments, the prosthesismay be attached to the spinous process 118 alone. However, theattachment members may be additionally or alternatively attached toother parts of the vertebra, such as but not limited to parts of thefacet 126 and/or to the pedicles 114 or any posterior portion of thespine, not just the spinous process 118. Other embodiments that attachto the pedicles 114 are described further hereinbelow.

Reference is now made to FIG. 3, which illustrates an elastomeric spinalprosthesis 39, constructed and operative in accordance with yet anotherembodiment of the present invention. Prosthesis 39 may be attached, forexample, to the spinous process 118 and to other vertebral structure,e.g., a facet 126 or pedicle 114 or any posterior portion of the spine(see FIGS. 1A and 1B; not shown in FIG. 3).

Prosthesis 39 may include an upper vertebral attachment member 40attachable to the spinous process 118, facet 126 and/or pedicle 114, anda lower vertebral attachment member 41 attachable to another portion ofthe spine (not shown), such as an adjacent spinous process 118, facet126 and/or pedicle 114. Attachment members 40 and 41 may be rigid ornon-rigid, as above. One or more elastomeric members 42 (two are shownin this example; elastomeric members 42 also being referred to as aflexure assembly) may be placed between and may be integrally formedwith or attached to upper and lower vertebral attachment members 40 and41. Elastomeric member 42, shown clearly in FIG. 6, may be made from acompliant material as above.

In the embodiment of FIG. 3, but not necessarily, upper and lowervertebral attachment members 40 and 41 may be formed with one or moremounting holes adapted for a mechanical fastener (not shown) to passthrough and into the portion of the spine. For example, any fastener orfasteners, such as but not limited to, screws, bolts, rivets, nails,tacks and nuts may pass through the mounting holes to firmly attachattachment members 40 and 41 to the spinous process 118.

FIGS. 4 and 5 are posterior perspective views of non-limiting examplesof upper and lower attachment members 40 and 41, respectively, as shownin FIG. 3. A mounting hole 44 is formed for attaching attachment member40 to the posterior of one of the spinous processes 118, for example.Another mounting hole 46 in member 40 may be for fixation to the rightfacet 126 of the same vertebra and yet another mounting hole 48 may befor fixation to the left facet 126 of the same vertebra. The three-pointfixation or attachment may provide a stable and more secure attachmentof member 40 to the vertebra posteriorly with a minimum amount ofinvasiveness.

In the embodiment of FIG. 3, but not necessarily, elastomeric member maybe attached to or integrally formed with upper and lower vertebralattachment members 40 and 41 by means of a tenon-and-mortise joint. Thetenon-and-mortise joint may comprise tenons 47 (protrusions) that matewith mortises (grooves) 49. However, the invention is not limited tothis type of joint or connection, and other types of joints,connections, fastenings, adhesive bonding and the like may also be used.

It is noted that the mounting holes may be placed and oriented in amultitude of manners. For example, in the embodiment of FIG. 1C, themounting holes 24 do not pass through a plane that intersectselastomeric member 22. The mounting holes 24 are generally transverse toa longitudinal axis of elastomeric member 22. In contrast, in theembodiment of FIG. 3, the mounting hole 44 passes through a plane thatintersects elastomeric member 42. The mounting holes 44, 46 and 48 aregenerally parallel to the longitudinal axis of elastomeric member 42.Other arrangements are also within the scope of the invention.

Reference is now made to FIGS. 7A, 7B, 8A and 8B, which illustrate anelastomeric spinal prosthesis 50, constructed and operative inaccordance with still another embodiment of the present invention.Prosthesis 50 may be attached, for example, to the spinous process 118and pedicles 114 (see FIGS. 1A and 1B; not shown in FIGS. 7A, 7B, 8A and8B).

Prosthesis 50 may include an upper (superior) vertebral attachmentmember 52 and a lower (inferior) vertebral attachment member 54. Theattachment members 52 and 54 may be attached to adjacent spinousprocesses 118, but as is described further hereinbelow, the prosthesis50 may be attached to pedicles without having to attach the attachmentmembers 52 and 54 to the spinous processes 118. Attachment members 52and 54 may be rigid or non-rigid, formed of materials including, but notlimited to, a biocompatible material such as a metal, e.g., stainlesssteel, titanium or titanium alloy, cobalt chromium alloys, plastics orother hard, rigid materials or any combination of the above.

A flexure assembly 56, comprising one or more flexing members (describedbelow), may be placed between and may be integrally formed with orattached to upper and lower vertebral attachment members 52 and 54.Flexure assembly 56 may be attached to upper and lower vertebralattachment members 52 and 54 by means of locking members 58. Lockingmembers 58 may include plate-like elements 59 secured to upper and lowervertebral attachment members 52 and 54 with mechanical fasteners 60,such as but not limited to, screws. Locking members 58 may furtherinclude lugs 61 extending generally perpendicularly from plate-likeelements 59, around which stoppers 62 are securedly engaged. Four suchstoppers 62 are shown in the illustrated embodiment, however, theinvention may be carried out with any number of such stoppers. A boot 64may be placed at least partially or fully around inner portions of theattachment members 52 and 54, e.g., at least partially or fully aroundthe locking members 58 and stoppers 62. The boot 64 may have anysuitable shape or size, such as but not limited to, a ring, a stocking,an ellipsoid and other shapes. As seen clearly in FIGS. 8A and 8B, theboot 64 is sandwiched between upper and lower vertebral attachmentmembers 52 and 54, and connected to locking members 58, such as but notnecessarily, by means of inner ridges 65 of boot 64 fixedly engaginggrooves 66 formed in plate-like elements 59 (as seen best in FIG. 8B).Thus, flexure assembly 56 comprises stoppers 62 and boot 64. The flexureassembly 56 may be constructed of a compliant, elastomeric materialincluding, but not limited to, polyurethane containing materials,silicone containing materials, polyethylene based elastomers, hydrogels,and polypropylene containing materials. Alternatively, the flexureassembly 56 may be constructed of rigid materials, such as stainlesssteel, for example. In any case, boot 64 is made of a compliantmaterial, such as but not limited to, an elastomer (e.g., polyurethane)or cloth (woven or non-woven synthetic or natural fibers).

The flexure assembly 56 permits flexure of prosthesis 50 about twomutually orthogonal axes 67 and 68, as well as other directions foromnidirectional flexure in any degree of freedom. For example, as seenin FIG. 8A, prosthesis 50 can resiliently rotate about axis 67 in thedirection of arrows 69. As seen in FIG. 8B, prosthesis 50 canresiliently rotate about axis 68 in the direction of arrows 70. Thestoppers 62 (as well as boot 64 to some extent) may limit the flexure offlexure assembly 56 and thus limit the relative movement of theattachment members 52 and 54 with respect to one another.

Depending from prosthesis 50 are pedicle screws 72 (FIGS. 7A and 7B) forinstalling prosthesis 50 into the pedicles 114. The pedicle screws 72may comprise, without limitation, polyaxial pedicle screws, e.g., madeof titanium or titanium alloy, commercially available in many sizes andshapes from many manufacturers. It is noted that titanium is highlyresistant to corrosion and fatigue, and is MRI compatible. The pediclescrew 72 may have a threaded shank 74 and a mobile, swivel head 75,whose ability to swivel may help avoid vertebral stress. The swivelheads 75 may be rotatably attached to rounded prongs 76 jutting fromupper and lower vertebral attachment members 52 and 54, by means of locknuts 77 that mate with heads 75.

In order to install prosthesis 50, a laminactomy may be performed,thereby creating a gap between the spinous processes 118, as mentionedhereinabove. The pedicle screws 72 may be screwed into the pedicles 114.The prosthesis 50 may be inserted in the gap between the spinousprocesses 118, with the rounded prongs 76 aligned with the heads 75 ofthe pedicle screws 72. The lock nuts 77 may then secure the prosthesis50 to the pedicle screws 72. As mentioned before, the prosthesis 50 maythus be attached to the pedicles without having to attach the attachmentmembers 52 and 54 to the spinous processes 118. Optionally, theattachment members 52 and 54 may also be attached to adjacent spinousprocesses 118 or other spinal structure by any convenient method. Theouter surfaces of attachment members 52 and 54 may be coated with amaterial, such as but not limited to, Hydroxy-Appatite (H/A), whichencourages bone growth into the outer surfaces thereof.

Reference is now made to FIGS. 8C and 8D, which illustrate analternative construction of the flexure assembly 56 of the elastomericspinal prosthesis 50. (The elastomeric boot 64 is omitted for clarity.)In this alternative construction, flexure assembly 56 may be constructedmay include a two-part articulating assembly, constructed of a firstjoint member 101, which may have a convex outer contour 102 with atruncated face 103. A semi-circular cutout 104 may be gouged out of theconvex outer contour 102. A plate 105 may secure the first joint member101 to the lower attachment member 54, such as with screws (not shown)that pass through mounting holes 106.

The other part of the two-part articulating assembly of flexure assembly56 may include a second joint member 107, which may have a concave outercontour 108 that corresponds to and glides over the convex outer contourof the first joint member 101. A plate 109 may secure the second jointmember 107 to the upper attachment member 52, such as with screws (notshown) that pass through mounting holes 110. A stopper 111 may beprovided, either as part of the second joint member 107 or as a separatepart attached to the upper attachment member 52. The stopper 111protrudes into the semi-circular cutout 104.

As similarly described above, this version of the flexure assembly 56shown in FIGS. 8C and 8D permits flexure of prosthesis 50 about twomutually orthogonal axes 67 and 68 as well as other directions foromnidirectional flexure in any degree of freedom. For example, as seenin FIG. 8A, prosthesis 50 can resiliently rotate about axis 67 in thedirection of arrows 69. As seen in FIG. 8B, prosthesis 50 canresiliently rotate about axis 68 in the direction of arrows 70. Thestopper 111 may limit the flexure of flexure assembly 56 and thus limitthe relative movement of the attachment members 52 and 54 with respectto one another.

It is noted that each of the spinal prostheses described hereinaboveinclude a unitary body with at least three attachment points attachableto spinal structure. By “unitary body” it is meant that the spinalprosthesis may be attached to the spinal structure as one pre-assembled,contiguous assembly. The surgeon can simply hold the entire unitary bodyin place during attachment to the spinal structure. This is in contrastto known prostheses that must be attached to the spinal structure as atleast two separate parts, which may or may not articulate with oneanother. With those prostheses, the surgeon must attach each partseparately to some spinal structure and merely “hope” that the parts fittogether properly after installment. The unitary construction of thepresent invention eliminates this problem and greatly facilitatesinstallation of the prosthesis.

Even though embodiments were described above in which the attachment ofattachment members was to either the spinous process alone or to thespinous process and to the facet or to the spinous process and topedicle of the particular vertebra, it is feasible that any combinationof the above embodiments will bring about similar results (such asstabilization of the spine, relief of pain, implantation of theprosthesis, etc.) and the above examples are just examples of attachmentsites and not in any way meant to be limiting. For example a superiorattachment member may be attached to a spinous process alone and theprosthesis's inferior attachment member may be attached to the adjacentvertebra's spinous process and to its pedicle or facet or even acombination of both. Similarly the prosthesis of this invention may beused in conjunction with an implant that is anterior to the spinal cordsuch as a total disc replacement.

Although the invention has been described in conjunction with specificembodiments thereof, many alternatives, modifications and variations areapparent to those skilled in the art. Accordingly, all suchalternatives, modifications and variations fall within the spirit andscope of the following claims.

1-28. (canceled)
 29. An article comprising: a spinal prosthesiscomprising a body with at least three attachment points attachable to aspinal structure, said body comprising a flexure assembly positionedbetween first and second attachment members, wherein flexure of saidflexure assembly permits movement of the first attachment memberrelative to the second attachment member, said spinal prosthesis wheninstalled in spinal structure of a patient having a posterior portioncorresponding to a posterior of the spinal structure; and a stopperadapted to limit movement in a posterior direction of one of saidattachment members relative to the other attachment member.
 30. Thearticle according to claim 29, wherein said stopper is also adapted tolimit movement of one of said attachment members relative to the otherattachment member along an axis perpendicular to the posteriordirection.
 31. The article according to claim 29, wherein said stopperis also adapted to limit rotational movement of one of said attachmentmembers relative to the other attachment member.
 32. The articleaccording to claim 29, further comprising pedicle screws for attachingthe first and second attachment members to spinal structure.